Method and system for providing integrated medication infusion and analyte monitoring system

ABSTRACT

Method and system for integrating infusion device and analyte monitoring system including medication infusion device such as an insulin pump and an analyte monitoring system such as a glucose monitoring system are provided.

RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 11/386,915 filed Mar. 21, 2006, which claims priority under 35USC §119(e) to provisional application No. 60/664,215 filed Mar. 21,2005 and assigned to the assignee of the present application, thedisclosure of each of which are incorporated herein in their entirety byreference for all purposes.

FIELD OF THE INVENTION

The present invention relates to methods and systems for integratinginfusion systems and analyte monitoring systems. More specifically, thepresent invention relates to methods and systems for integrating insulininfusion devices with continuous analyte monitoring systems.

BACKGROUND OF THE INVENTION

Type 1 diabetics must periodically be administered with insulin tosustain their physiological conditions. Typically, these patientsadminister doses of either fast acting or slow acting insulin usingneedle type syringes, for example, prior to meals, and/or at a suitabletime during the course of each day contemporaneously with the bloodglucose level testing using fingerstick testing, for example. If insulinis not suitably administered, the diabetic patients risk serious if notfatal damage to the body.

Continued development and improvement in the external infusion pumptherapy in recent years have drawn much appeal to the diabetic patientsfor, among others, improved management of diabetes by better regulatingand controlling the intake of insulin. Typically, the patient inserts acannula which is connected to an infusion tubing attached to an externalpump, and insulin is administered based on preprogrammed basal profiles.Moreover, the external infusion devices presently available includecomputational capability to determined suitable bolus doses such ascarbohydrate bolus and correction bolus, for example, to be administeredin conjunction with the infusion device executing the patient's basalprofile.

The basal profiles are generally determined by the patients' physicianor caretaker and are based on a number of factors including thepatient's insulin sensitivity and physiological condition which arediagnosed by the patient's physician, for example, and are typicallyintended to as accurately estimate the patient's glucose levels over apredetermined time period during which the patient is infusing insulin.The glucose levels may be estimated based on the patient's periodicdiscrete testing using a test strip and a blood glucose meter such asFreestyle® Glucose Meter available from Abbott Diabetes Care, Inc., ofAlameda, Calif. Such estimations are, however, prone to error, and donot accurately mirror the patient's actual physiological condition.

SUMMARY OF THE INVENTION

In view of the foregoing, it would be desirable to have an integratedsystem combining the functionalities of an infusion device such asinsulin infusion pumps, and analyte monitoring systems such ascontinuous glucose monitoring systems.

These and other objects, features and advantages of the presentinvention will become more fully apparent from the following detaileddescription of the embodiments, the appended claims and the accompanyingdrawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates an integrated infusion device and analyte monitoringsystem in accordance with one embodiment of the present invention;

FIG. 2 illustrates an integrated infusion device and analyte monitoringsystem in accordance with another embodiment of the present invention;

FIG. 3 illustrates an integrated infusion device and analyte monitoringsystem in accordance with yet another embodiment of the presentinvention;

FIG. 4 illustrates an integrated infusion device and analyte monitoringsystem in accordance with still another embodiment of the presentinvention;

FIG. 5 illustrates an integrated infusion device and analyte monitoringsystem in accordance with still a further embodiment of the presentinvention;

FIG. 6 illustrates an integrated infusion device and monitoring systemin accordance with yet still a further embodiment of the presentinvention;

FIG. 7A illustrates the integrated infusion device and monitoring systemshown in FIG. 6 in further detail in one embodiment of the presentinvention, while FIGS. 7B-7C illustrate the analog front end circuitrylocated at the patient interface and the pump assembly, respectively, ofthe integrated infusion device and monitoring system shown in FIG. 7A inaccordance with one embodiment of the present invention;

FIGS. 8A-8C illustrate a passive sensor configuration for use in acontinuous analyte monitoring system, and two embodiments of an activesensor configuration for use at the patient interface in the integratedinfusion device and monitoring system, respectively, in accordance withone embodiment of the present invention;

FIG. 9 illustrates an integrated infusion device and analyte monitoringsystem with the infusion device and the monitoring system transmitterintegrated into a single patch worn by the patient in accordance withone embodiment of the present invention;

FIG. 10 is a detailed view of the infusion device cannula integratedwith analyte monitoring system sensor electrodes in accordance with oneembodiment of the present invention;

FIG. 11A illustrates a component perspective view of the infusion devicecannula integrated with analyte monitoring system sensor electrodes inaccordance with another embodiment of the present invention, while FIG.11B illustrates a top planar view of the analyte monitoring systemtransmitter unit integrated with the infusion device in accordance withone embodiment of the present invention;

FIGS. 12A-12C each illustrate a cross sectional view of the infusiondevice cannula integrated with continuous analyte monitoring systemsensor electrodes of FIG. 10 in accordance with the various embodimentsrespectively, of the present invention; and

FIG. 13 is a timing chart for illustrating the temporal spacing of bloodglucose measurement and insulin delivery by the integrated infusiondevice and monitoring system in one embodiment.

DETAILED DESCRIPTION

FIG. 1 illustrates an integrated infusion device and analyte monitoringsystem in accordance with one embodiment of the present invention.Referring to FIG. 1, the integrated infusion device and analytemonitoring system 100 in one embodiment of the present inventionincludes an infusion device 110 connected to an infusion tubing 130 forliquid transport or infusion, and which is further coupled to a cannula170. As can be seen from FIG. 1, the cannula 170 is configured to bemountably coupled to a transmitter unit 150, where the transmitter unit150 is also mountably coupled to an analyte sensor 160. Also provided isan analyte monitor unit 120 which is configured to wirelesslycommunicate with the transmitter unit 150 over a communication path 140.

Referring to FIG. 1, in one embodiment of the present invention, thetransmitter unit 150 is configured for unidirectional wirelesscommunication over the communication path 140 to the analyte monitorunit 120. In one embodiment, the analyte monitor unit 120 may beconfigured to include a transceiver unit (not shown) for bi-directionalcommunication over the communication path 140. The transmitter unit 150in one embodiment may be configured to periodically and/orintermittently transmit signals associated with analyte levels detectedby the analyte sensor 160 to the analyte monitor unit 120. The analytemonitor unit 120 may be configured to receive the signals from thetransmitter unit 150 and in one embodiment, is configured to performdata storage and processing based on one or more preprogrammed orpredetermined processes.

For example, in one embodiment, the analyte monitor unit 120 isconfigured to store the received signals associated with analyte levelsin a data storage unit (not shown). Alternatively, or in addition, theanalyte monitor unit 120 may be configured to process the signalsassociated with the analyte levels to generate trend indication by, forexample, visual display of a line chart or an angular icon based displayfor output display on its display unit 121. Additional information maybe output displayed on the display unit 121 of the analyte monitor unit120 including, but not limited to, the substantially contemporaneous andreal time analyte level of the patient received from the transmitterunit 150 as detected by the sensor 160. The real time analyte level maybe displayed in a numeric format or in any other suitable format whichprovides the patient with the accurate measurement of the substantiallyreal time analyte level detected by the sensor 160.

Additional analytes that may be monitored or determined by the sensor160 include, for example, acetyl choline, amylase, bilirubin,cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB),creatine, DNA, fructosamine, glucose, glutamine, growth hormones,hormones, ketones, lactate, peroxide, prostate-specific antigen,prothrombin, RNA, thyroid stimulating hormone, and troponin. Theconcentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be determined.

Referring back to FIG. 1, the sensor 160 may include a short term (forexample, 3 day, 5 day or 7 day use) analyte sensor which is replacedafter its intended useful life. Moreover, in one embodiment, the sensor160 is configured to be positioned subcutaneous to the skin of thepatient such that at least a portion of the analyte sensor is maintainedin fluid contact with the patient's analyte such as, for example,interstitial fluid or blood. In addition, the cannula 170 which isconfigured to similarly be positioned under the patient's skin isconnected to the infusion tubing 130 of the infusion device 110 so as todeliver medication such as insulin to the patient. Moreover, in oneembodiment, the cannula 170 is configured to be replaced with thereplacement of the sensor 160.

In one aspect of the present invention, the cannula 170 and the sensor160 may be configured to be subcutaneously positioned under the skin ofthe patient using an insertion mechanism (not shown) such as aninsertion gun which may include, for example, a spring biased or loadedinsertion mechanism to substantially accurately position the cannula 170and the sensor 160 under the patient's skin. In this manner, the cannula170 and the sensor 160 may be subcutaneously positioned withsubstantially little or no perceived pain by the patient. Alternatively,the cannula 170 and/or the sensor 160 may be configured to be manuallyinserted by the patient through the patient's skin. After positioningthe cannula 170 and the sensor 160, they may be substantially firmlyretained in position by an adhesive layer 180 which is configured toadhere to the skin of the patient for the duration of the time periodduring which the sensor 160 and the cannula 170 are subcutaneouslypositioned.

Moreover, in one embodiment, the transmitter unit 150 may be mountedafter the subcutaneous positioning of the sensor 160 and the cannula 170so as to be in electrical contact with the sensor electrodes. Similarly,the infusion tubing 130 may be configured to operatively couple to thehousing of the transmitter unit 150 so as to be accurately positionedfor alignment with the cannula 170 and to provide a substantially watertight seal. Additional detailed description of the analyte monitoringsystem including the sensor 160, transmitter unit 150 and the analytemonitor unit 120 is provided in U.S. Pat. No. 6,175,752, assigned to theassignee of the present invention, Abbott Diabetes Care Inc.

Referring back to FIG. 1, the infusion device 110 may includecapabilities to program basal profiles, calculation of bolus dosesincluding, but not limited to, correction bolus, carbohydrate bolus,extended bolus, and dual bolus, which may be performed by the patientusing the infusion device 110, and may be based on one or more factorsincluding the patient's insulin sensitivity, insulin on board, intendedcarbohydrate intake (for example, for the carbohydrate bolus calculationprior to a meal), the patient's measured or detected glucose level, andthe patient's glucose trend information. In a further embodiment, thebolus calculation capabilities may also be provided in the analytemonitor unit 120.

In one embodiment, the analyte monitor unit 120 is configured with asubstantially compact housing that can be easily carried by the patient.In addition, the infusion device 110 similarly may be configured as asubstantially compact device which can be easily and conveniently wornon the patient's clothing (for example, housed in a holster or acarrying device worn or clipped to the patient's belt or other parts ofthe clothing). Referring yet again to FIG. 1, the analyte monitor unit120 and/or the infusion device 110 may include a user interface such asinformation input mechanism by the patient as well as data outputincluding, for example, the display unit 121 on the analyte monitor unit120, or similarly a display unit 111 on the infusion device 110.

One or more audio output devices such as, for example, speakers orbuzzers may be integrated with the housing of the infusion device 110and/or the analyte monitor unit 120 so as to output audible alerts oralarms based on the occurrence of one or more predetermined conditionsassociated with the infusion device 110 or the analyte monitor unit 120.For example, the infusion device 110 may be configured to output anaudible alarm or alert to the patient upon detection of an occlusion inthe infusion tubing 130 or the occurrence of a timed event such as areminder to prime the infusion tubing 130 upon replacement of thecannula 170, and the like. The analyte monitor unit 120 may similarly beconfigured to output an audible alarm or alert when a predeterminedcondition or a pre-programmed event occurs, such as, for example, areminder to replace the sensor 160 after its useful life (of 3 days, 5days or 7 days), or one or more alerts associated with the data receivedfrom the transmitter unit 150 corresponding to the patient's monitoredanalyte levels. Such alerts or alarms may include a warning alert to thepatient that the detected analyte level is beyond a predeterminedthreshold level, or the trend of the detected analyte levels within agiven time period is indicative of a significant condition such aspotential hyperglycemia or hypoglycemia, which require attention orcorrective action. It is to be noted that the examples of audible alarmsand/or alerts are described above for illustrative purposes only, thatwithin the scope of the present invention, other events or conditionsmay be programmed into the infusion device 110 or the analyte monitorunit 120 or both, so as to alert or notify the patient of the occurrenceor the potential occurrence of such events or conditions.

In addition, within the scope of the present invention, audible alarmsmay be output alone, or in combination with one or more of a visualalert such as an output display on the display unit 111, 121 of theinfusion device 110 or the analyte monitor unit 120, respectively, orvibratory alert which would provide a tactile indication to the patientof the associated alarm and/or alert.

Moreover, referring yet again to FIG. 1, while one analyte monitor unit120 and one transmitter unit 150 are shown, within the scope of thepresent invention, additional analyte monitor units or transmitter unitsmay be provided such that, for example, the transmitter unit 150 may beconfigured to transmit to multiple analyte monitor units substantiallysimultaneously. Alternatively, multiple transmitter units coupled tomultiple sensors concurrently in fluid contact with the patient'sanalyte may be configured to transmit to the analyte monitor unit 120,or to multiple analyte monitor units. For example, an additionaltransmitter unit coupled to an additional sensor may be provided in theintegrated infusion device 110 and analyte monitoring system 100 whichdoes not include the cannula 170, and which may be used to performfunctions associated with the sensor 160 such as sensor calibration,sensor data verification, and the like.

In one embodiment, the transmitter unit 150 is configured to transmitthe sampled data signals received from the sensor 160 withoutacknowledgement from the analyte monitor unit 120 that the transmittedsampled data signals have been received. For example, the transmitterunit 150 may be configured to transmit the encoded sampled data signalsat a fixed rate (e.g., at one minute intervals) after the completion ofthe initial power on procedure. Likewise, the analyte monitor unit 120may be configured to detect such transmitted encoded sampled datasignals at predetermined time intervals. Alternatively, the transmitterunit 150 and the analyte monitor unit 120 may be configured forbi-directional communication over the communication path 140.

Additionally, in one aspect, the analyte monitor unit 120 may includetwo sections. The first section of the analyte monitor unit 120 mayinclude an analog interface section that is configured to communicatewith the transmitter unit 150 via the communication path 140. In oneembodiment, the analog interface section may include a radio frequency(RF) receiver and an antenna for receiving and amplifying the datasignals from the transmitter unit 150, which are thereafter, demodulatedwith a local oscillator and filtered through a band-pass filter. Thesecond section of the analyte monitor unit 120 may include a dataprocessing section which is configured to process the data signalsreceived from the transmitter unit 150 such as by performing datadecoding, error detection and correction, data clock generation, anddata bit recovery, for example.

In operation, upon completing the power-on procedure, the analytemonitor unit 120 is configured to detect the presence of the transmitterunit 150 within its range based on, for example, the strength of thedetected data signals received from the transmitter unit 150 or apredetermined transmitter identification information. Upon successfulsynchronization with the transmitter unit 150, the analyte monitor unit120 is configured to begin receiving from the transmitter unit 150 datasignals corresponding to the patient's detected analyte, for exampleglucose, levels.

Referring again to FIG. 1, the analyte monitor unit 120 or the infusiondevice 110, or both may be configured to further communicate with a dataprocessing terminal (not shown) which may include a desktop computerterminal, a data communication enabled kiosk, a laptop computer, ahandheld computing device such as a personal digital assistant (PDAs),or a data communication enabled mobile telephone, and the like, each ofwhich may be configured for data communication via a wired or a wirelessconnection. The data processing terminal for example may includephysician's terminal and/or a bedside terminal in a hospitalenvironment, for example.

The communication path 140 for data communication between thetransmitter unit 150 and the analyte monitor unit 120 of FIG. 1 mayinclude an RF communication link, Bluetooth communication link, infraredcommunication link, or any other type of suitable wireless communicationconnection between two or more electronic devices. The datacommunication link may also include a wired cable connection such as,for example, but not limited to an RS232 connection, USB connection, orserial cable connection.

Referring yet again to FIG. 1, in a further aspect of the presentinvention, the analyte monitor unit 120 or the infusion device 110 (orboth) may also include a test strip port configured to receive a bloodglucose test strip for discrete sampling of the patient's blood forglucose level determination. An example of the functionality of theblood glucose test strip meter unit may be found in the Freestyle® BloodGlucose Meter available from the assignee of the present invention,Abbott Diabetes Care Inc.

In the manner described above, in one embodiment of the presentinvention, the cannula 170 for infusing insulin or other suitablemedication is integrated with the adhesive patch 180 for the sensor 160and the transmitter unit 150 of the analyte monitoring system.Accordingly, only one on-skin patch can be worn by the patient (forexample, on the skin of the abdomen) rather than two separate patchesfor the infusion device cannula 170, and the analyte monitoring systemsensor 160 (with the transmitter unit 150). Thus, the Type-1 diabeticpatient may conveniently implement infusion therapy in conjunction withreal time glucose monitoring while minimizing potential skin irritationon the adhesive patch 180 site on the patient's skin, and thus providemore insertion sites with less irritation.

In addition, the integrated infusion device and analyte monitoringsystem 100 as shown in FIG. 1 may be configured such that the infusiontubing 130 may be disconnected from the infusion device 110 as well asfrom the housing of the transmitter 150 (or the adhesive patch 180) suchthat, optionally, the patient may configure the system as a continuousanalyte monitoring system while disabling the infusion device 110functionality.

Moreover, in accordance with one embodiment of the present invention,the patient may better manage the physiological conditions associatedwith diabetes by having substantially continuous real time glucose data,trend information based on the substantially continuous real timeglucose data, and accordingly, modify or adjust the infusion levelsdelivered by the infusion device 110 from the pre-programmed basalprofiles that the infusion device 110 is configured to implement.

FIG. 2 illustrates an integrated infusion device and analyte monitoringsystem in accordance with another embodiment of the present invention.Referring to FIG. 2, the integrated infusion device and analytemonitoring system 200 in one embodiment of the present inventionincludes an integrated infusion device and analyte monitor unit 210which is coupled to an infusion tubing 220 connected to the cannula 260.Also shown in FIG. 2 is a transmitter unit 240 which is in electricalcontact with an analyte sensor 250, where the cannula 260 and theanalyte sensor 250 are subcutaneously positioned under the skin of thepatient, and retained in position by an adhesive layer or patch 270.

Referring to FIG. 2, the integrated infusion device 200 and analytemonitor unit 210 is configured to wirelessly communicate with thetransmitter unit 240 over a communication path 230 such as an RFcommunication link. Compared with the embodiment shown in FIG. 1, it canbe seen that in the embodiment shown in FIG. 2, the infusion device andthe analyte monitor are integrated into a single housing 210. In thismanner, the transmitter unit 240 may be configured to transmit signalscorresponding to the detected analyte levels received from the analytesensor 250 to the integrated infusion device and 200 analyte monitorunit 210 for data analysis and processing.

Accordingly, the patient may conveniently receive real time glucoselevels from the transmitter unit 240 and accordingly, determine whetherto modify the existing basal profile(s) in accordance with which insulinis delivered to the patient. In this manner, the functionalities of theanalyte monitor unit may be integrated within the compact housing of theinfusion device to provide additional convenience to the patient by, forexample, providing the real time glucose data as well as other relevantinformation such as glucose trend data to the user interface of theinfusion device, so that the patient may readily and easily determineany suitable modification to the infusion rate of the insulin pump.

In one embodiment, the configurations of each component shown in FIG. 2including the cannula 260, the analyte sensor 250, the transmitter unit240, the adhesive layer 270, the communication path 230, as well as theinfusion tubing 220 and the functionalities of the infusion device andthe analyte monitor are substantially similar to the correspondingrespective component as described above in conjunction with FIG. 1.

Accordingly, in one embodiment of the present invention, the additionalconvenience may be provided to the patient in maintaining and enhancingdiabetes management by, for example, having a single integrated devicesuch as the integrated infusion device and analyte monitor unit 210which would allow the patient to easily manipulate and manage insulintherapy using a single user interface system of the integrated infusiondevice and analyte monitor unit 210. Indeed, by providing many of theinformation associated with the glucose levels and insulin infusioninformation in one device, the patient may be provided with theadditional convenience in managing diabetes and improving insulintherapy.

FIG. 3 illustrates an integrated infusion device and analyte monitoringsystem in accordance with yet another embodiment of the presentinvention. Referring to FIG. 3, the integrated infusion device andanalyte monitoring system 300 in one embodiment of the present inventionincludes an infusion device 310 connected to an infusion tubing 340coupled to a cannula 370. The cannula 370 is configured to be positionedsubcutaneously under the patient's skin and substantially retained inposition by an adhesive layer 380. Also retained in position, asdiscussed above and similar to the embodiments described in conjunctionwith FIGS. 1-2, is an analyte sensor 360 also positioned subcutaneouslyunder the patient's skin and maintained in fluid contact with thepatient's analyte. A transmitter unit 350 is provided so as to beelectrically coupled to the analyte sensor 360 electrodes. Also, as canbe seen from FIG. 3, in one embodiment, the infusion tubing 340 isconnected to the housing of the transmitter unit 350 so as to connect tothe cannula 370 disposed under the patient's skin.

Referring to FIG. 3, also provided is an analyte monitor unit 320configured to wirelessly communicate with the transmitter unit 350 toreceive data therefrom associated with the analyte levels of the patientdetected by the analyte sensor 360. Referring to FIG. 3, in oneembodiment, the infusion device 310 does not include a user interfacesuch as a display unit and/or an input unit such as buttons or a jogdial. Instead, the user interface and control mechanism is provided onthe analyte monitoring unit 320 such that the analyte monitoring unit320 is configured to wirelessly control the operation of the infusiondevice 310 and further, to suitably program the infusion device 310 toexecute pre-programmed basal profile(s), and to otherwise control thefunctionality of the infusion device 310.

More specifically, all of the programming and control mechanisms for theinfusion device 310 are provided in the analyte monitoring unit 320 suchthat when the patient is wearing the infusion device 310, it may be worndiscreetly under clothing near the infusion site on the patient's skin(such as abdomen), while still providing convenient access to thepatient for controlling the infusion device 310 through the analytemonitoring unit 320.

In addition, in one embodiment, the configurations of each componentshown in FIG. 3 including the cannula 370, the analyte sensor 360, thetransmitter unit 350, the adhesive layer 380, the communication path330, as well as the infusion tubing 340 and the functionalities of theinfusion device and the analyte monitoring unit 320 are substantiallysimilar to the corresponding respective component as described above inconjunction with FIG. 1. However, the infusion device 310 in theembodiment shown in FIG. 3 is configured with a transceiver or anequivalent communication mechanism to communicate with the analytemonitoring unit 320.

In this manner, in one embodiment of the present invention,configuration of the infusion device 310 without a user interfaceprovides a smaller and lighter housing and configuration for theinfusion device 310 which would enhance the comfort in wearing and/orcarrying the infusion device 310 with the patient. Moreover, since thecontrol and programming functions of the infusion device 310 areprovided on the analyte monitoring unit 320, the patient mayconveniently program and/or control the functions and operations of theinfusion device 310 without being tethered to the infusion tubing 340attached to the cannula 370 which is positioned under the patient'sskin. In addition, since the programming and control of the infusiondevice 310 is remotely performed on the analyte monitoring unit 320, theinfusion tubing 340 may be shorter and thus less cumbersome.

FIG. 4 illustrates an integrated infusion device and analyte monitoringsystem in accordance with still another embodiment of the presentinvention. Referring to FIG. 4, the integrated infusion device andanalyte monitoring system 400 in one embodiment of the present inventionincludes an infusion device 410 configured to wirelessly communicatewith an analyte monitoring unit 420 over a communication path 430 suchas an RF (radio frequency) link. In addition, as can be further seenfrom FIG. 4, the infusion device 410 is connected to an infusion tubing440 which has provided therein integral wires connected to the analytesensor electrodes. As discussed in further detail below, the measuredanalyte levels of the patient is received by the infusion device 410 viathe infusion tubing 440 and transmitted to the analyte monitoring unit420 for further processing and analysis.

More specifically, referring to FIG. 4, the integrated infusion deviceand analyte monitoring system 400 includes a patch 450 provided with acannula 470 and an analyte sensor 460. The cannula 470 is configured todeliver or infuse medication such as insulin from the infusion device410 to the patient. That is, in one embodiment, the cannula 470 and theanalyte sensor 460 are configured to be positioned subcutaneous to thepatient's skin. The analyte sensor 460 is configured to be positioned tobe in fluid contact with the patient's analyte.

In this manner, the analyte sensor 460 is electrically coupled tointegral wires provided within the infusion tubing 440 so as to providesignals corresponding to the measured or detected analyte levels of thepatient to the infusion device 410. In one embodiment, the infusiondevice 410 is configured to perform data analysis and storage, such thatthe infusion device 410 may be configured to display the real timemeasured glucose levels to the patient on its display unit 411. Inaddition to, or alternatively, the infusion device 410 is configured towirelessly transmit the received signals from the analyte sensor 460 tothe analyte monitoring unit 420 for data analysis, display, and/orstorage and the analyte monitoring unit 420 may be configured toremotely control the functions and features of the infusion device 410,providing additional user convenience and discreteness.

Referring back to FIG. 4, in one embodiment, the patch 450 may beconfigured to be substantially small without a transmitter unit mountedthereon, and provided with a relatively small surface area to beattached to the patient's skin. In this manner, the patient may beprovided with added comfort in having a substantially compact housingmounted on the skin (attached with an adhesive layer, for example), toinfuse medication such as insulin, and for continuous analyte monitoringwith the analyte sensor 460.

FIG. 5 illustrates an integrated infusion device and analyte monitoringsystem in accordance with still a further embodiment of the presentinvention. As compared with the embodiment shown in FIG. 4, theintegrated infusion device and analyte monitoring system 500 of FIG. 5includes an integrated infusion device and analyte monitoring unit 510.Accordingly, one user interface is provided to the user including thedisplay unit 511 and input buttons 512 provided on the housing of theintegrated infusion device and analyte monitoring unit 510. Also shownin FIG. 5 is infusion tubing 520 with integral wires disposed thereinand connected to an analyte sensor 540 electrodes in fluid contact withthe patient's analyte. Moreover, as can be seen from FIG. 5, an adhesivepatch 530 is provided to retain the subcutaneous position of a cannula550 and the analyte sensor 540 in the desired positions under thepatient's skin.

Optionally, the integrated infusion device and analyte monitoring unit510 may be provided with wireless or wired communication capability soto communicate with a remote terminal such as a physician's computerterminal over a wireless communication path such as RF communicationlink, or over a cable connection such as a USB connection, for example.Referring back to FIG. 5, in one embodiment of the present invention,the diabetic patient using an infusion therapy is provided with lesscomponents to handle or manipulate further simplifying insulin therapyand glucose level monitoring and management.

FIG. 6 illustrates an integrated infusion device and monitoring systemin accordance with yet still a further embodiment of the presentinvention. Referring to FIG. 6, the integrated infusion device andanalyte monitoring system 600 is provided with an infusion devicewithout a user interface, and configured to wirelessly communicate withan analyte monitoring unit 620 over a communication path 630 such as anRF link. The infusion device 610 which may be provided in a compacthousing since it does not incorporate the components associated with auser interface, is connected to an infusion tubing 640 having disposedtherein integral wires correspondingly connected to the electrodes ofanalyte sensor 660 in fluid contact with the patient's analyte. Inaddition, the compact adhesive patch 650 in one embodiment is configuredto retain cannula 670 and the analyte sensor 660 in the desired positionunder the skin of the patient.

Similar to the embodiment shown in FIG. 3, the analyte monitoring unit620 is configured to control and program the infusion device 610 overthe communication link 630. In this manner, the control and programmingfunctions of the infusion device 610 may be remotely performed by theanalyte monitoring unit 620, providing convenience to the patient.

FIG. 7A illustrates the integrated infusion device and monitoring systemshown in FIG. 6 in further detail in one embodiment of the presentinvention, while FIGS. 7B-7C illustrate the analog front end circuitrylocated at the patient interface and the pump assembly, respectively, ofthe integrated infusion device and monitoring system shown in FIG. 7A inaccordance with one embodiment of the present invention. Referring toFIG. 7A, an infusion device 710 connected to an infusion tubing 720 withintegral wires provided therein for connection to the electrodes of theanalyte sensor is shown. The infusion tubing 720 is further connected toan adhesive patch 730 which is configured to retain cannula 750 andanalyte sensor 740 in the desired subcutaneous position under the skinof the patient.

Referring to FIG. 7A, in one embodiment of the present invention, theinfusion device 710 may be provided with a first analog front endcircuitry unit 711, while the adhesive patch may be provided with asecond analog front end circuitry unit 731. The integral wires from theanalyte sensor 740 is configured to extend from the infusion device 710to the adhesive layer 730 via the infusion tubing 720. Since the analytesensor 740 in one embodiment is a passive component, the signals on theworking electrode and the reference electrodes of the analyte sensorsare subject to noise given the high impedance of the electrodes and thelength of the integral wires (in excess of a few centimeters). The noisein turn may potentially adversely affect the signals on the working andreference electrodes which may distort the measured analyte levelsdetected by the analyte sensor 740.

Given the length of the integral wire which corresponds to the length ofthe infusion tubing 720, in one embodiment, the signals from the workingand reference electrodes may be converted to low impedance signals tominimize adverse impact from the noise. Accordingly, the infusion device710 may be provided with a first analog front end circuitry unit 711,while the adhesive patch 730 may be provided with a second analog frontend circuitry unit 731 as discussed in further detail below inconjunction with FIGS. 7B and 7C.

Referring now to FIG. 7B, the second analog front end circuitry unit 731disposed on the adhesive patch 730 on the patient's skin, in oneembodiment includes a trans-impedance amplifier (current to voltageconverter or “I-to-V”) 731A configured to convert the working electrode(W) current to a voltage (Vw), and to provide a guard signal (G), and aservo segment 731B to drive the counter electrode (C) voltage (Vc) basedon the reference electrode (R) voltage. Also shown in FIG. 7B is aLow-Pass Filter (LPF) and gain stage 711A that follow each of the I-to-Vand servo stages, and which is configured in one embodiment to drive anA/D (Analog-to-Digital) converter unit 711C whose results are read by acontroller such as a central processing unit (CPU) 711D. The A/Dconverter unit 711C and the CPU 711D and other peripherals may becombined into a single integrated circuit (IC) known as amicrocontroller (μC) such as the MSP430 product line.

Referring now to FIG. 7C, in one embodiment, the second analog front endcircuitry unit 731 may be implemented by a pair of operationalamplifiers (731A and 731B), four resistors (R1, R2, R3, Rf), and abypass capacitor (Cb). The I-to-F stage using operational amplifier 731Ais generated by the action of the input current from the workingelectrode (W) flowing through the feedback resistor (Rf) and creating avoltage differential that is driven by the operational amplifier 731A asthe low impedance signal Vw. The offset for the Vw signal is establishedby the resistor divider comprised of R1, R2 and R3 which also createsthe voltage of the guard signal (G)—a signal that is at the samepotential or voltage as the working electrode (W).

The servo, using operational amplifier 731B, in one embodiment, drivesthe counter electrode (C) voltage to the sensor so that the referenceelectrode (R) is at the second value set by the resistor dividercomprised of resistors R1, R2 and R3. This maintains the workingelectrode (W) voltage above the reference electrode (R) by a set amountknown as the “Poise Voltage” (i.e. 40 mV). The bypass capacitor (Cb) maybe a small, low equivalent series resistance (ESR) capacitor, such as a0.1 uF (100 nF) multi-layer ceramic (MLC) capacitor, that acts toprovide local energy and reduce noise on the circuit. The voltage sourcefor this circuit may be provided by the potential difference between V+and V− where, for example, V+ may be 5V and V− may be ground (GND) or V+may be +3V and V− may be −3V.

In one embodiment, the operational amplifiers 731A, 731B may be acquiredas a dual operational amplifier integrated circuit (IC) in a single,small 8-pin, surface mount technology (SMT) package such as the OPA2349in a SOT23-8 package (3 mm by 3 mm). Similar dual operational amplifierproducts may be available in even smaller ball-grid array (BGA) packagesand as bare die that may be mounted directly to the circuit substrate,such as a printed circuit board (PCB) or flex circuit, using techniquessuch as “flip-chip” and wire-bond.

FIGS. 8A-8C illustrate a passive sensor configuration for use in acontinuous analyte monitoring system, and two embodiments of an activesensor configuration for use at the patient interface in the integratedinfusion device and monitoring system, respectively, in accordance withone embodiment of the present invention. Referring to FIG. 8A, analytesensor 810 includes working electrode 811, a guard trace 812, areference electrode 813, and a counter electrode 814. In one embodiment,the “tail” segment 815 of the analyte sensor 810 is configured to bepositioned subcutaneously under the patient's skin so as to be in fluidcontact with the patient.

Referring now to FIG. 8B, analyte sensor 820 is provided with the analogfront end portion 821 where the four contacts shown are V+, V−, Vw, andVc signals in accordance with one embodiment in place of the workingelectrode 811, a guard trace 812, a reference electrode 813, and acounter electrode 814, respectively. In this manner, in one embodimentof the present invention, these signals of the active analyte sensor 820are low impedance and thus less subject to noise than the passive sensorsignals. Moreover, in one embodiment, the analyte sensor 820configuration may include a flex circuit.

Referring now to FIG. 8C, in a further embodiment, an active sensor ofsimilar construction to the active sensor 820 of FIG. 8B but with muchsmaller dimensions is shown. More specifically, analyte sensor 830 isprovided with four contacts configured for direct wire bonding ratherthan a mechanical contact system as indicated by the large contact areason the previous two sensor configurations shown in FIGS. 8A-8B. Sincethe shape of the analyte sensor 830 is reduced, the sensor 830 may bewrapped around the cannula (for example, cannula 470 of FIG. 4) and thusonly a single entry site may be required for the patient analytemonitoring and insulin infusion. Moreover, within the scope of thepresent invention, additional sensor/cannula configurations may beprovided where the sensor circuitry and cannula are created as a singleassembly such as a cannula with the circuit 831 fabricated on thesurface.

FIG. 9 illustrates an integrated infusion device and analyte monitoringsystem with the infusion device and the monitoring system transmitterintegrated into a single patch worn by the patient in accordance withone embodiment of the present invention. Referring to FIG. 9, theintegrated infusion device and analyte monitoring system 900 includes anintegrated patch pump and transmitter unit 910 provided on an adhesivelayer 960, which is configured to be placed on the skin of the patient,so as to securely position cannula 950 and analyte sensor 940subcutaneously under the skin of the patient. The housing of theintegrated infusion pump and transmitter unit 910 is configured in oneembodiment to include the infusion mechanism to deliver medication suchas insulin to the patient via the cannula 950.

In addition, the integrated patch pump and transmitter unit 910 isconfigured to transmit signals associated with the detected analytelevels measured by the analyte sensor 940, over a wireless communicationpath 930 such as an RF link. The signals are transmitted from the onbody integrated patch pump and transmitter unit 910 to a controller unit920 which is configured to control the operation of the integrated patchpump and transmitter unit 910, as well as to receive the transmittedsignals from the integrated patch pump and transmitter unit 910 whichcorrespond to the detected analyte levels of the patient.

Referring back to FIG. 9, in one embodiment, the infusion mechanism ofthe integrated patch pump and transmitter unit 910 may include theinfusion device of the type described in U.S. Pat. No. 6,916,159assigned to the assignee of the present invention Abbott Diabetes CareInc. In addition, while a wireless communication over the communicationpath 930 is shown in FIG. 9, the wireless communication path 930 may bereplaced by a set of wires to provide a wired connection to thecontroller unit 920.

In this manner, in one embodiment of the present invention, theintegrated infusion device and analyte monitoring system 900 does notuse an infusion tubing which may provide additional comfort andconvenience to the patient by providing additional freedom from havingto wear a cumbersome tubing.

FIG. 10 is a detailed view of the infusion device cannula integratedwith analyte monitoring system sensor electrodes in accordance with oneembodiment of the present invention. Referring to FIG. 10, there isshown an infusion device cannula with analyte sensor electrodes 1020disposed therein, and mounted to an adhesive patch 1010 so as to retainits position securely in the patient. More specifically, as can be seenfrom FIG. 10, the cannula with analyte sensor electrodes 1020 includesensor electrodes 1021, 1022, 1023 (which may correspond to working,reference and counter electrodes, respectively) each of which areprovided within the cannula tip 1020, and further, positioned so as tomaintain fluid contact with the patient's analyte.

FIGS. 12A-12C each illustrate a cross sectional view of the infusiondevice cannula integrated with continuous analyte monitoring systemsensor electrodes of FIG. 10 in accordance with the various embodimentsrespectively, of the present invention. Referring to FIG. 12A, in oneembodiment, the wire and tubing are provided in parallel such that thetubing wall 1220, the tube bore for insulin flow 1224, the wire outercasing 1220 and the individual insulated wires 1221, 1222, 1223 aresubstantially provided as shown in FIG. 12A. More specifically, it canbe seen from the Figure that each of the three insulated wires areprovided with an insulation layer 1020 of tubing wall individuallysurrounding each insulated wires 1221, 1222, 1223, and further, wherethe three insulated wires 1221, 1222, 1223 are in turn surrounded by thetubing wall 1220.

Referring now to FIG. 12B in one embodiment of the present invention,the insulated wires 1221, 1222, 1223 respectively connected to thesensor electrodes are co-extruded into tubing wall 1220, with the tubebore 1224 for insulin delivery and the insulated wires 1221, 1222, 1223configured substantially as shown in the FIG. 12B. Referring now to FIG.12C, in still a further embodiment of the present invention, each of theinsulated wires 1221, 1222, and 1223 are wrapped around the tubing 1220and covered with a sheath 1210, thus providing the tubing wall 1220, thetubing bore 1224 for insulin delivery, the individual insulated wires1221, 1222, 1223, and the outer protective sheath 1210, which may alsoserve as an electromagnetic shield to eliminate electronic noise assubstantially shown in the Figure.

Referring again to the Figures, the embodiments shown in FIGS. 12A and12C may have a larger cross-sectional area (thus a larger hole needed tobe punctured on the skin of the patient), but are likely easier tomanufacture, and more reliable and easier to make connection to theanalyte sensor electronics). Additionally, within the scope of thepresent invention, an optical data transmission (i.e. fiber optics)along insulin delivery tubing between sensor and pump may be providedinstead of integral wires as discussed above.

FIG. 11A illustrates a component perspective view of the infusion devicecannula integrated with analyte monitoring system sensor electrodes inaccordance with another embodiment of the present invention, while FIG.11B illustrates a top planar view of the analyte monitoring systemtransmitter unit integrated with an infusion device in accordance withone embodiment of the present invention. Referring to FIGS. 11A-11B, inone embodiment of the present invention, integrated analyte sensor andinfusion device cannula 1100 comprises five laminated layers including atop insulation layer 1101, a conductive layer 1102 with electrode tracesdisposed thereon, followed by three layer substrate with integratedinfusion cannula 1103.

In one embodiment, the three layer substrate with integrated infusioncannula 1103 includes a separation/insulation layer 1103A to insulatethe sensor electrodes from the infusion cannula, a channel layer 1103Bconfigured to guide the flow of the insulin or any other suitablemedication, and an inlet/outlet layer 1103C. Also shown in FIG. 11A isan assembled view of the integrated analyte sensor and infusion devicecannula 1100.

Referring now to FIG. 11B, it can be seen that a patch pump as shown inone embodiment is provided with a transmitter unit 1110 and an insulinpump 1130 coupled to insulin reservoir 1120, and operatively coupled ormounted to the transmitter unit 1110. Also shown in FIG. 11B is theanalyte sensor contacts 1140 which are configured to establishelectrical contact with the respective electrodes of the integratedinfusion cannula and analyte sensor 1100. Also shown in FIG. 11B isinsulin port 1150 which is connected to the channel layer 1103B of theintegrated infusion device cannula and analyte sensor 1100.

In this manner, in one embodiment of the present invention, the patchpump may be worn by the patient on skin and which includes the insulininfusion mechanism as well as the analyte sensor and transmitter unit.

FIG. 13 is a timing chart for illustrating the temporal spacing of bloodglucose measurement and insulin delivery by the integrated infusiondevice and monitoring system in one embodiment. More specifically,insulin pumps typically deliver insulin in a periodic manner with theperiod of delivery in the range of 2 to 3 minutes and the duration ofdelivery at each period being on the order of a few seconds or less. Theamount of insulin that is delivered each period may be varied dependingon the overall insulin delivery rate that is desired. The analyte datais collected continuously (as, for example, a continuous current ofglucose oxidation) but is typically reported to the user periodically.The analyte reporting period is typically 1 to 10 minutes and glucoseoxidation current needs to be collected for 10 to 30 seconds in order togenerate a reportable glucose value (to allow for filtering etc.).

Indeed, the integration of analyte monitoring and insulin delivery maynecessitate placement of a analyte sensor in close proximity to aninsulin infusion cannula on the body. Such close proximity engenders thepossibility of insulin delivery interfering with the analytemeasurements. For example, if insulin infusion should result in alocalized decrease in the glucose concentration in the area of the bodynear the infusion site, then glucose measurement in this area would notbe representative of the glucose concentration in the body as a whole.Accordingly, in one embodiment of the present invention, there isprovided a method for temporal spacing of blood glucose measurements andinsulin delivery to mitigate the possible interference between insulininfusion and glucose measurements.

In accordance with one embodiment, the temporal spacing of analytemeasurement and insulin delivery may include providing as large atemporal gap from after insulin delivery and before taking a analytemeasurement. Since both analyte measurement and insulin delivery areperformed periodically, a maximum spacing in time may be achieved ifanalyte measurement substantially immediately precedes insulin delivery.During the time between insulin delivery and the subsequent glucosemeasurement, infused insulin has time to diffuse and be transported awayfrom the infusion site due to normal circulation of interstitial fluid.An example timeline of temporally spaced analyte measurement and insulindelivery is shown in FIG. 13. If multiple analyte measurements are takenbetween insulin delivery points, there should always be a reading justprior to insulin delivery and as well just after insulin delivery tominimize the affect of injected insulin on the glucose measurementreadings.

Although readings are typically taken periodically for simplicity inprocessing, a reading may be taken out of time with other readings andscaled appropriately for the overall reading average. Similarly, theinsulin delivery point may be delayed slightly until after the readingwith little or no affect as the readings typically occur much morefrequently than the infusions, which are intended to act over longerperiods of time. In addition, other timing considerations may beconsidered depending on the environment in which the integrated infusiondevice and analyte monitoring system is used by the patient, within thescope of the present invention to minimize potential error on measuredanalyte levels and/or introduce noise or potential adverse effects tothe infusion rates of the infusion device.

More specifically, fluctuation in the power supplies of the infusiondevice and/or the analyte monitoring system including, for example,batteries or related power distribution circuitry may introduceelectrical noise effects which may adversely affect the measuredreadings associated with the analyte monitoring system. For example,when the analyte monitoring system is configured to be in an activestate so as to be transmitting or receiving data, or when the pump cycleof the infusion device is active, the power supply may be affected bythe load from the data transmission/reception, or the pumping cycle. Theadverse effect of the power supply in addition to noise from othercomponents of the electronic circuitry may introduce undesirable noiseand adversely affect the accuracy of the analyte sensor measurements.

Accordingly, the transmitter unit 150 (FIG. 1) for example, may beconfigured to monitor the timing or occurrence of the measured analytelevel received from the analyte sensor 160 and the data transmissiontiming of the transmitter unit 150 such that the two events do notsubstantially overlap or occur at substantially the same time.Alternatively, the analyte monitor unit 120 (FIG. 1) may be configuredto compare the timing of the analyte sensor 160 measurement and thetiming of the data transmission from the transmitter unit 150, and todiscard analyte related data received from the transmitter unit 150which coincide with the timing of the analyte measurements by theanalyte sensor 160.

Moreover in one embodiment, air bubble detection in the insulin tubingmay be provided, by monitoring fluid motion that would also detect theabsence of fluid such as that due to an air bubble in the line. In oneembodiment, the flow sensor may be configured to generate zero currentwhen an air bubble is present.

In addition, colorization of insulin may be provided for air bubbledetection in the tubing. Since pharmaceutical insulin is a clearcolorless liquid, it is difficult to visually discriminate betweeninsulin and air in tubing that carries insulin from the insulin pump tothe cannula. By providing a color tint to the insulin it would be mucheasier to visually identify air bubbles in the tubing and be able toremove them before they cause problems. An insulin tint in oneembodiment is biocompatible and insulin compatible.

Accordingly, a system including an infusion device and an analytemonitoring unit in one embodiment of the present invention includes aninfusion device, an on-body unit including a data transmission section,the on-body unit further coupled to the infusion device, the on-bodyunit configured to receive one or more signals corresponding to arespective one or more analyte levels, and further, the on-body unitconfigured to infuse a fluid received from the infusion device, and areceiver unit operatively coupled to the on-body unit, the receiver unitconfigured to receive data from the on-body unit, wherein the receiveddata is associated with the analyte level.

The system may further include an analyte sensor at least a firstportion of which is in fluid contact with an analyte of a patient, andfurther, where at a second portion of the analyte sensor is in signalcommunication with the data transmission section.

The data transmission section may in one embodiment be configured totransmit the one or more signals corresponding to a respective one ormore analyte levels substantially periodically at one or morepredetermined time intervals, where the one or more predetermined timeintervals may include one or more of 30 seconds, one minute, or 90seconds.

In one aspect, the on-body unit may include a cannula at least a portionof which is subcutaneously positioned under a skin layer, and further,may also include an infusion tubing connected to the infusion device todeliver the fluid to the on-body unit. The infusion tubing and theon-body unit in a further aspect may be connected in a substantiallywater tight seal.

In yet another embodiment, the infusion tubing may be configured tooperatively couple to the cannula to deliver the fluid.

The on-body unit may be configured to wirelessly transmit the one ormore signals corresponding to the respective one or more analyte levelsto the receiver unit, where the on-body unit and the receiver may beconfigured to wirelessly communicate over one or more of an RFcommunication link, a Bluetooth® communication link, or an infraredcommunication link.

In addition, the infusion device in a further embodiment may beconfigured to control the delivery rate of the fluid based on the one ormore signals corresponding to the respective one or more analyte levelsreceived by the receiver unit, and further, where the infusion devicemay be configured to determine a modified delivery protocol fordelivering fluid such as insulin based on information associated withthe one or more signals corresponding to the respective one or moreanalyte levels.

In yet another aspect, the modified delivery protocol may include one ormore of a correction bolus, a modified basal profile, a carbohydratebolus, an extended bolus, or combinations thereof.

The receiver unit in one embodiment may be configured to wirelesslycommunicate with the infusion device.

In a further embodiment, the receiver unit maybe integrated into ahousing of the infusion device.

A method of integrating analyte monitoring and fluid infusion in anotherembodiment of the present invention includes infusing a fluid at apredetermined delivery rate, detecting one or more analyte levels,transmitting one or more signals associated with the respective detectedone or more analyte levels, and determining a modified delivery ratebased on the transmitted one or more signals.

In one aspect, the one or more signals may be transmitted substantiallyimmediately after the associated respective one or more analyte levelsare detected.

Moreover, the transmitting step in one embodiment may include wirelesslytransmitting the one or more signals which wirelessly transmitted overone or more of an RF communication link, a Bluetooth® communicationlink, an infrared communication link, or combinations thereof.

The method in a further aspect may also include the steps of receivingthe transmitted one or more signals, and displaying the received one ormore signals.

Moreover, the method may also include the step of displaying themodified delivery rate. In addition, the method may also include thestep of implementing the modified delivery rate, where the predetermineddelivery rate may include one or more basal delivery rates.

The modified delivery rate in a further embodiment may include one ormore of a correction bolus, a modified basal profile, a carbohydratebolus, an extended bolus, or combinations thereof.

An apparatus including an analyte sensor and a fluid delivery channel inyet another embodiment of the present invention includes a fluiddelivery unit having an inner wall and an outer wall, and a plurality ofelectrodes disposed between the inner wall and the outer wall of thefluid delivery unit, where a portion of the of the fluid delivery unitand a portion of the plurality of electrodes are subcutaneouslypositioned under a skin layer.

In one aspect, the plurality of electrodes may comprise an analytesensor, including, for example, one or more of a working electrode, acounter electrode, a reference electrode, or combinations thereof.

The fluid delivery unit may include a channel for delivering a fluidsuch as insulin, the channel substantially formed by the inner wall.

An apparatus including an analyte sensor and a fluid delivery channel inaccordance with still another embodiment of the present inventionincludes a first tubing having a first tubing channel, and a secondtubing having a second tubing channel including a plurality ofelectrodes disposed within the second tubing channel, where at least aportion of the first tubing and at least a portion of the second tubingare subcutaneously positioned under a skin layer.

In one embodiment, the plurality of the electrodes may be substantiallyand entirely insulated from each other.

In another embodiment, the first tubing and the second tubing may beintegrally formed such that an outer surface of the first tubing issubstantially in contact with an outer surface of the second tubing.

A system including an infusion device and an analyte monitoring unit inaccordance with still another embodiment of the present inventionincludes an infusion and monitoring device, an on-body unit including adata transmission section, the on-body unit further coupled to theinfusion and monitoring device, the on-body unit configured to receiveone or more signals corresponding to a respective one or more analytelevels, and further, the on-body unit configured to infuse a fluidreceived from the infusion and monitoring device, and a connectorcoupled at a first end to the infusion device, and further, coupled at asecond end to the on-body unit, the connector configured to channel thefluid from the infusion device to the on-body unit, and further,configured to provide the one or more signals corresponding to therespective one or more analyte levels to the infusion and monitoringdevice.

In one aspect, the infusion and monitoring device may be configured toexecute fluid delivery to a patient, and further, to detect analytelevels of the patient over a predetermined time period.

In a further aspect, the infusion and monitoring device may include acontinuous glucose monitoring system.

In still another aspect, the infusion and monitoring device may includean insulin pump.

A method of fluid delivery and analyte monitoring in accordance withstill another embodiment of the present invention includes determining adelivery profile for fluid infusion, wherein the delivery profileincluding a plurality of predetermined discrete fluid infusion eachtemporally separated by a predetermined time period, and sampling ananalyte level substantially immediately prior to each predetermineddiscrete fluid infusion.

The method may further include the step of sampling an analyte levelsubstantially immediately after each predetermined discrete fluidinfusion.

Various other modifications and alternations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments.

1. A glucose monitoring device, comprising: a device housing including adisplay for outputting one or more of a graphical information oralphanumeric information; a data communication connection provided inthe housing including one or more of a wired communication section or awireless communication section; a strip port coupled to the housing andconfigured to receive an in vitro test strip; and a controlleroperatively coupled to the data communication connection and the stripport and provided in the device housing, the controller configured todetermine a blood glucose level based on a blood sample on the teststrip, the controller further configured to process analyte sensor datacorresponding to a monitored analyte level; wherein the determined bloodglucose level or the processed analyte sensor data or both, are outputon the display graphically or alphanumerically or based on a combinationthereof; and further wherein the controller is in signal communicationwith an on-body patch pump via the data communication connection andincludes a memory having instructions stored which, when executed by oneor more processors, causes the on-body patch pump to deliver amedication based on the delivery profile, wherein the delivery profileincludes a plurality of predetermined discrete medication infusionstemporally separated by a predetermined time period, and wherein thememory having instructions stored which, when executed by the processor,obtains at least one of the plurality of signals associated with themonitored analyte level substantially immediately prior to the deliveryof each of the predetermined discrete medication infusions.
 2. Thedevice of claim 1 wherein the wired communication section includes aUniversal Serial Bus (USB) connection physically coupled to the devicehousing, and configured to establish wired data communication to a dataprocessing terminal.
 3. The device of claim 2 wherein the determinedblood glucose level or the processed analyte sensor data or both aretransferred to the data processing terminal based on the USB connection.4. The device of claim 1 wherein the analyte sensor data is receivedusing the wireless communication section.
 5. The device of claim 4wherein the wireless communication section includes a radio frequency(RF) communication section.
 6. The device of claim 1 wherein thecontroller is configured to communicate with an infusion device via thedata communication connection.
 7. The device of claim 6 wherein thecontroller transmits one or more signals to the infusion device tocontrol the delivery rate of a fluid based on the one or more analytesensor data.
 8. The device of claim 7 wherein the fluid is insulin. 9.The device of claim 1 wherein the analyte sensor data includes analytesensor data received from an in vivo glucose sensor.
 10. The device ofclaim 1 including an input unit provided on the housing to enter one ormore input commands to the device.
 11. The device of claim 10 whereinthe input unit includes one or more of a button or a jog dial.
 12. Thedevice of claim 1 wherein the controller is further configured todetermine a medication dose.
 13. The device of claim 12 wherein thecontroller is configured to execute the determined medication dose. 14.The device of claim 12 wherein the controller is configured to determinethe medication dose based at least in part on the determined bloodglucose level or the processed analyte sensor data or both.
 15. Thedevice of claim 12 wherein the medication dose is output on the displaygraphically or alphanumerically or based on a combination thereof. 16.The device of claim 12 wherein the medication dose includes a bolusdose.
 17. The device of claim 16 wherein the bolus dose includes acorrection bolus, a carbohydrate bolus, an extended bolus, a dual bolus,or one or more combinations thereof.
 18. The device of claim 12 whereinthe controller determines the medication dose based on one or more of aninsulin sensitivity information, insulin on board information, intendedcarbohydrate intake information, measured glucose level, detectedglucose level, or glucose trend information.
 19. A device, comprising: adevice housing including a display for outputting one or more of agraphical information or alphanumeric information; a data communicationconnection provided in the housing including one or more of a wiredcommunication section or a wireless communication section; a strip portcoupled to the housing and configured to receive an in vitro test strip;and a controller operatively coupled to the data communicationconnection and the strip port and provided in the device housing, thecontroller configured to determine a blood glucose level based on ablood sample on the test strip and to process analyte sensor datacorresponding to a monitored analyte level, the controller furtherconfigured to determine a medication dose based at least in part on oneor more of the determined blood glucose level or the processed analytesensor data; wherein one or more of the determined blood glucose level,the processed analyte sensor data, or the determined medication dose,are output on the display graphically or alphanumerically or based on acombination thereof; wherein the graphical output on the displayincludes an analyte level trend information; and further wherein thecontroller is in signal communication with an on-body patch pump via thedata communication connection and includes a memory having instructionsstored which, when executed by one or more processors, causes theon-body patch pump to deliver a medication based on the deliveryprofile, wherein the delivery profile includes a plurality ofpredetermined discrete medication infusions temporally separated by apredetermined time period, and wherein the memory having instructionsstored which, when executed by the processor, obtains at least one ofthe plurality of signals associated with the monitored analyte levelsubstantially immediately prior to the delivery of each of thepredetermined discrete medication infusions.
 20. The device of claim 19wherein the wired communication section includes a Universal Serial Bus(USB) connection physically coupled to the device housing, andconfigured to establish wired data communication to a data processingterminal.
 21. The device of claim 20 wherein the determined bloodglucose level or the processed analyte sensor data or both aretransferred to the data processing terminal based on the USB connection.22. The device of claim 19 wherein the analyte sensor data is receivedusing the wireless communication section.
 23. The device of claim 22wherein the wireless communication section includes a radio frequency(RF) communication section.
 24. The device of claim 19 wherein thecontroller is configured to communicate with an infusion device via thedata communication connection.
 25. The device of claim 24 wherein thecontroller transmits one or more signals to the infusion device tocontrol the delivery rate of a fluid based on the one or more analytesensor data.
 26. The device of claim 25 wherein the delivery rate of thefluid is related to the determined medication dose.
 27. The device ofclaim 25 wherein the fluid is insulin.
 28. The device of claim 19wherein the analyte sensor data includes analyte sensor data receivedfrom an in vivo glucose sensor.
 29. The device of claim 19 including aninput unit provided on the housing to enter one or more input commandsto the device.
 30. The device of claim 29 wherein the input unitincludes one or more of a button or a jog dial.
 31. The device of claim19 wherein the controller is configured to execute the determinedmedication dose.
 32. The device of claim 19 wherein the medication doseincludes a bolus dose.
 33. The device of claim 32 wherein the bolus doseincludes a correction bolus, a carbohydrate bolus, an extended bolus, adual bolus, or one or more combinations thereof.
 34. The device of claim19 wherein the controller determines the medication dose based on one ormore of an insulin sensitivity information, insulin on boardinformation, intended carbohydrate intake information, measured glucoselevel, detected glucose level, or glucose trend information.